FDA Enforcement
Class II
Ongoing
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Recall: Z-1450-2026
·
Reported March 4, 2026
Enforcement
- Recall Number
- Z-1450-2026
- Event ID
- 98288
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 4, 2026
- Initiation Date
- November 11, 2025
- Classification Date
- February 20, 2026
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Reason
Complaints of the ceramic tip of the resection sheath breaking have been received.
Code Info
Model No. WA22017A; UDI: 04042761051514; All Lots.
Distribution
US Nationwide Distribution.
Quantity
437 units